MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112264-001

Device Problem Mechanical Problem (1384)

Patient Problems Embolism (1829); Ischemia (1942); Occlusion (1984); Sepsis (2067)

Event Date 07/26/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced an embolism and complications.A 2.1mm jetstream xc was selected for an atherectomy procedure in the popliteal artery above the knee in the left leg.Atherectomy was performed with blades down and blades up with the jetstream device; however atheroembolization occurred occluding the distal popliteal artery and tibial arteries.The physician noted that the device malfunctioned, possibly due to the short length of the lesion being treated.After embolectomy restoring flow to the posterior tibial artery (pta) and perineal there was diminished collateral flow to the foot from the anterior tibial artery (ata) and occluded distal popliteal artery (dpa).The patient had worse hemodynamics on follow up ultrasound with tbi dropping from.2 to 0 and ultimately developed a critically ischemic limb and sepsis resulting in above knee amputation.The popliteal and tibial arteries were patent prior to treatment and immediately following atherectomy they were occluded.Aspiration embolectomy was then performed with a non-bsc aspiration catheter of the popliteal, ata, tpt, peroneal.Infusion of nitroglycerine, verapamil and tissue plasminogen activator (tpa) were administered.Angioplasty of the tibial arteries and pedal arteries was performed.An un-specified stent was placed in the popliteal artery.A 100cc visipaque contract was administered.Continuous iv drip and flush for sheath.No critical abnormalities were noted.

• Brand Name: JETSTREAM ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7842619
• MDR Text Key: 119082677
• Report Number: 2134265-2018-60538
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2020
• Device Model Number: 112264-001
• Device Catalogue Number: 45007
• Device Lot Number: 0021921357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 62 YR